PainPhase 3NCT01132794
A Study to Assess the Analgesia and Sedation Using Intranasal Dexmedetomidine in Third Molar Surgery Under Local Anaesthesia
A Phase 3 study testing Intranasal dexmedetomidine in people with Pain and Sedation, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Dental procedures such as wisdom tooth removal evoke very high levels of patients' anxiety and it is, therefore, common practice to provide concomitant pharmacologic sedation. Sedative agents can be administered by the oral, rectal, intra muscular and intravenous routes. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- What is being tested?
- Intranasal dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteHong Kong
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) 1 or 2
- Age >18 and less than 40 years
- Unilateral wisdom tooth removal
- Written informed consent
Who cannot join
- Allergy to dexmedetomidine and propofol
- Patient refusal
- Mentally unfit
- Impaired renal or hepatic function
- Pregnant
- Exposure to study drug within the past 3 months.
Show all 11Show fewer
- Use ofα2 agonists currently
- Patients with cardiac disease
- Abnormal electrocardiogram
- Inability to complete psychomotor test
- Addictive in illicit drugs or alcohol
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Anaesthesiology, The University of Hong Kong
Hong Kong
About this study
Dental procedures such as wisdom tooth removal evoke very high levels of patients' anxiety and it is, therefore, common practice to provide concomitant pharmacologic sedation.
Sedative agents can be administered by the oral, rectal, intra muscular and intravenous routes. The oldest, safest and most convenient route at present is the oral route. However, as Uygur-Bayramicli et al. mentioned that administering the drugs orally can result in problems like delayed effect. Intranasal administration is a straightforward procedure. It is simple and relatively painless. Although it may be objectionable, less patient cooperation is required than with oral administration, especially in which the child must swallow the medication.
Read more
Many studies on dental sedation have been carried out by anesthesiologists but there is no ideal drug that can offer effects of both sedation and analgesia. Some drugs offer only one effect and others are not safe enough for clinical use. Midazolam, a benzodiazepine drug, is the traditional choice for sedation, but it has properties such as relatively slow onset and no analgesia. Propofol is an alkylphenol sedative and hypnotic agent with a rapid onset and offset. It has been used in patient controlled sedation before. But it has no analgesic properties. It can provide some antegrade amnesia, but it is not as reliable an amnestic as the benzodiazepine drugs. Because of these characteristics, propofol often is supplemented with narcotics and benzodiazepines. Although not irritant, it can cause pain during intravenous infusion.
A new drug, an alpha agonist with its relatively high ratio of α2/α1-activity (1620:1 as compared with 220:1 for clonidine) of theα2 receptor is dexmedetomidine. This property may lead to more potent effects of both sedation and analgesia without unwanted cardiovascular effects fromα1 receptor activation. Most of the data evaluating the use of dexmedetomidine in the intensive care unit (ICU) were obtained in the immediate postoperative period, mainly in patients who underwent open-heart surgery. Currently, clinicians are awaiting studies in broader patient populations. In the studies that have been completed to date, sedation has been attained easily with maintenance of respiratory function. Patients are readily arousable. There is a minimal increase in blood pressure initially, followed by a slight decrease in blood pressure. Lower dose ranges, avoidance of rapid bolus injection, and a slow rate of administration tend to decrease these circulatory side effects. So many clinical studies have shown that it can be well and safely used intravenously, intramuscularly and transdermally. Although not an officially technique, there are also reports of intranasal administration resulting in fairly predictable onset in both adults and children.
The investigators propose that intranasal can help to improve postoperative pain relief with better sedation.
- Being tested
- Intranasal dexmedetomidine, Placebo
- Keywords
- Pain relief and sedation condition
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal dexmedetomidineDrug
1mcg per kg dexmedetomidine given intranasally 45 minutes before operation
PlaceboDrug
Intranasal nasal saline
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Intranasal nasal saline Receives: Drug: Placebo |
| Dexmedetomidine | Active comparator | Intranasal dexmedetomidine Receives: Drug: Intranasal dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores after operation
Secondary outcomes (1)
Sedation satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132794
- Sponsor's protocol ID
- 200707176037
- Status last verified
- May 2010
- First submitted
- 24 May 2010
- Last updated
- 16 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Analgesia and Sedation Using Intranasal Dexmedetomidine in Third Molar Surgery Under Local Anaesthesia
- ClinicalTrials.gov ID
- NCT01132794
- Acronym / sponsor ID
- 200707176037
- Keywords
- Pain relief and sedation condition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- First posted
- 28 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dental procedures such as wisdom tooth removal evoke very high levels of patients' anxiety and it is, therefore, common practice to provide concomitant pharmacologic sedation.
Sedative agents can be administered by the oral, rectal, intra muscular and intravenous routes. The oldest, safest and most convenient route at present is the oral route. However, as Uygur-Bayramicli et al. mentioned that administering the drugs orally can result in problems like delayed effect. Intranasal administration is a straightforward procedure. It is simple and relatively painless. Although it may be objectionable, less patient cooperation is required than with oral administration, especially in which the child must swallow the medication.
Many studies on dental sedation have been carried out by anesthesiologists but there is no ideal drug that can offer effects of both sedation and analgesia. Some drugs offer only one effect and others are not safe enough for clinical use. Midazolam, a benzodiazepine drug, is the traditional choice for sedation, but it has properties such as relatively slow onset and no analgesia. Propofol is an alkylphenol sedative and hypnotic agent with a rapid onset and offset. It has been used in patient controlled sedation before. But it has no analgesic properties. It can provide some antegrade amnesia, but it is not as reliable an amnestic as the benzodiazepine drugs. Because of these characteristics, propofol often is supplemented with narcotics and benzodiazepines. Although not irritant, it can cause pain during intravenous infusion.
A new drug, an alpha agonist with its relatively high ratio of α2/α1-activity (1620:1 as compared with 220:1 for clonidine) of theα2 receptor is dexmedetomidine. This property may lead to more potent effects of both sedation and analgesia without unwanted cardiovascular effects fromα1 receptor activation. Most of the data evaluating the use of dexmedetomidine in the intensive care unit (ICU) were obtained in the immediate postoperative period, mainly in patients who underwent open-heart surgery. Currently, clinicians are awaiting studies in broader patient populations. In the studies that have been completed to date, sedation has been attained easily with maintenance of respiratory function. Patients are readily arousable. There is a minimal increase in blood pressure initially, followed by a slight decrease in blood pressure. Lower dose ranges, avoidance of rapid bolus injection, and a slow rate of administration tend to decrease these circulatory side effects. So many clinical studies have shown that it can be well and safely used intravenously, intramuscularly and transdermally. Although not an officially technique, there are also reports of intranasal administration resulting in fairly predictable onset in both adults and children.
The investigators propose that intranasal can help to improve postoperative pain relief with better sedation.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboIntranasal nasal saline |
| Dexmedetomidine | Active comparator | Drug: Intranasal dexmedetomidineIntranasal dexmedetomidine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) 1 or 2
- Age >18 and less than 40 years
- Unilateral wisdom tooth removal
- Written informed consent
Key exclusion criteria (11 listed)
- Allergy to dexmedetomidine and propofol
- Patient refusal
- Mentally unfit
- Impaired renal or hepatic function
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal dexmedetomidine1mcg per kg dexmedetomidine given intranasally 45 minutes before operation | Drug | Dexmedetomidine |
| PlaceboIntranasal nasal saline | Drug | Placebo |
Primary outcome
Pain scores after operation
1 secondary outcome
Sedation satisfaction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intranasal dexmedetomidine in people with Pain and Sedation, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores after operation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2010.